Burkitt LymphomaPhase 2NCT00001237
Pilot Protocol for the Treatment of Patients With Small Non-Cleaved and Diffuse Large Cell Lymphomas
A Phase 2 study testing granulocyte-macrophage colony stimulating factor (GM-CSF) in people with Burkitt Lymphoma and Lymphoma, Large-Cell, Diffuse, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place in the last ten years. Though the survival rate in low risk patients (i.e., those with stage I \& II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous Pediatric Branch protocol, only 32% of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burkitt Lymphoma, Lymphoma, Large-Cell, Diffuse, Lymphoma, Small Noncleaved-Cell
- What is being tested?
- granulocyte-macrophage colony stimulating factor (GM-CSF)
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1989to Apr 2000
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
High Risk Protocol: Patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas except those with:
- Minimal extra-abdominal tumor as the sole site of disease and a serum LDH less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L) or except those with b) completely resected small, localized abdominal mass (involved segmental lymph nodes permitted) and a serum LDH level less than 1.5 times upper limit of normal (NIH patients less than 350 U/L).
All patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with a serum LDH level greater than 1.5 times the upper limit of normal (NIH patients, greater than 350 U/L), regardless of the clinically documented extent of disease.
All patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with testicular involvement.
Low risk protocol: Patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with a) minimal extra-abdominal disease as the sole site of disease and a serum LDH less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L) or b) completely resected small, localized abdominal mass (involved segmental lymph nodes permitted for gastrointestinal disease) and a serum LDH level less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L).
No patients with lymphoblastic lymphomas, low grade or follicular lymphomas.
No patients with peripheral T cell lymphomas that do not fall into the category of anaplastic large cell lymphoma.
No patients with a previously documented lymphoma or histological evidence of co-existing lymphoma of other histology.
No patients who have been previously treated with chemotherapy or radiotherapy.
No patients with HIV infection.
No patients above the age of 60 years.
No patients with a history of inherited or non-HIV acquired immunodeficiency syndromes.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place in the last ten years. Though the survival rate in low risk patients (i.e., those with stage I \& II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous Pediatric Branch protocol, only 32% of patients in the high risk group achieved long term remission. The present protocol is designed to improve survival in the high risk group by using alternating non-cross resistant drug regimens. We plan to determine whether using granulocyte-macrophage colony stimulating factor (GM-CSF) in this group would increase dose-intensity and ameliorate myelotoxicity. We also plan to study the effect on survival of decreasing the duration of treatment to three months from the present year-long therapy in low-risk patients.
Read the detailed description
Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place in the last ten years. Though the survival rate in low risk patients (i.e., those with stage I \& II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous Pediatric Branch protocol, only 32% of patients in the high risk group achieved long term remission. The present protocol is designed to improve survival in the high risk group by using alternating non-cross resistant drug regimens. We plan to determine whether using granulocyte-macrophage colony stimulating factor (GM-CSF) in this group would increase dose-intensity and ameliorate myelotoxicity. We also plan to study the effect on survival of decreasing the duration of treatment to three months from the present year-long therapy in low-risk patients.
- Being tested
- granulocyte-macrophage colony stimulating factor (GM-CSF)
- Keywords
- Burkitt's Lymphoma, GM-CSF, High-Grade
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
granulocyte-macrophage colony stimulating factor (GM-CSF)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1989
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burkitt LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001237
- Sponsor's protocol ID
- 890041
- Other IDs
- 89-C-0041
- Status last verified
- Jan 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Magrath I, Barriga F, McManaway M, Shiramizu B. The molecular analysis of chromosomal translocations as a diagnostic, epidemiological and potentially prognostic tool in lymphoid neoplasia. J Virol Methods. 1988 Sep;21(1-4):275-89. doi: 10.1016/0166-0934(88)90073-0.
PubMed 3053744Pelicci PG, Knowles DM 2nd, Magrath I, Dalla-Favera R. Chromosomal breakpoints and structural alterations of the c-myc locus differ in endemic and sporadic forms of Burkitt lymphoma. Proc Natl Acad Sci U S A. 1986 May;83(9):2984-8. doi: 10.1073/pnas.83.9.2984.
PubMed 3458257Magrath IT, Janus C, Edwards BK, Spiegel R, Jaffe ES, Berard CW, Miliauskas J, Morris K, Barnwell R. An effective therapy for both undifferentiated (including Burkitt's) lymphomas and lymphoblastic lymphomas in children and young adults. Blood. 1984 May;63(5):1102-11.
PubMed 6546890
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Protocol for the Treatment of Patients With Small Non-Cleaved and Diffuse Large Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00001237
- Acronym / sponsor ID
- 890041
- Keywords
- Burkitt's Lymphoma, GM-CSF, High-Grade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 1989
- Study completion
- Apr 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place in the last ten years. Though the survival rate in low risk patients (i.e., those with stage I \& II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous Pediatric Branch protocol, only 32% of patients in the high risk group achieved long term remission. The present protocol is designed to improve survival in the high risk group by using alternating non-cross resistant drug regimens. We plan to determine whether using granulocyte-macrophage colony stimulating factor (GM-CSF) in this group would increase dose-intensity and ameliorate myelotoxicity. We also plan to study the effect on survival of decreasing the duration of treatment to three months from the present year-long therapy in low-risk patients.
Detailed description
Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place in the last ten years. Though the survival rate in low risk patients (i.e., those with stage I \& II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous Pediatric Branch protocol, only 32% of patients in the high risk group achieved long term remission. The present protocol is designed to improve survival in the high risk group by using alternating non-cross resistant drug regimens. We plan to determine whether using granulocyte-macrophage colony stimulating factor (GM-CSF) in this group would increase dose-intensity and ameliorate myelotoxicity. We also plan to study the effect on survival of decreasing the duration of treatment to three months from the present year-long therapy in low-risk patients.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| granulocyte-macrophage colony stimulating factor (GM-CSF) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 3053744Magrath I, Barriga F, McManaway M, Shiramizu B. The molecular analysis of chromosomal translocations as a diagnostic, epidemiological and potentially prognostic tool in lymphoid neoplasia. J Virol Methods. 1988 Sep;21(1-4):275-89. doi: 10.1016/0166-0934(88)90073-0.
- Background: PubMed 3458257Pelicci PG, Knowles DM 2nd, Magrath I, Dalla-Favera R. Chromosomal breakpoints and structural alterations of the c-myc locus differ in endemic and sporadic forms of Burkitt lymphoma. Proc Natl Acad Sci U S A. 1986 May;83(9):2984-8. doi: 10.1073/pnas.83.9.2984.
- Background: PubMed 6546890Magrath IT, Janus C, Edwards BK, Spiegel R, Jaffe ES, Berard CW, Miliauskas J, Morris K, Barnwell R. An effective therapy for both undifferentiated (including Burkitt's) lymphomas and lymphoblastic lymphomas in children and young adults. Blood. 1984 May;63(5):1102-11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing granulocyte-macrophage colony stimulating factor (GM-CSF) in people with Burkitt Lymphoma and Lymphoma, Large-Cell, Diffuse, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001237, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.